PHA 338 - Intro and Capsules L16

What are the advantages of solid dosage forms?

Convenient to self-administer, inexpensive, light/easy to carry, tasteless, easy identification, and long shelf life.

Which solid dosage form is the most widely used?

Oral solid dosage forms.

Why are tablets and capsules convenient?

They are easy for patients to self-administer.

Which solid dosage form is generally the least expensive?

Tablets.

Why are solid dosage forms easy to carry?

They are lightweight.

Why are many solid dosage forms considered tasteless?

The drug is enclosed within the dosage form.

Why is identification of capsules and tablets easy?

They can be color-coded and imprinted.

What is an advantage of the shelf life of solid dosage forms?

They generally have a long shelf life.

What is a powder?

Fine particles of a solid drug and/or excipients.

What processes are often required before using powders?

Particle size reduction and sifting.

What dosage forms can powders be used to prepare?

Capsules, tablets, suspensions, inhalations, ointments, and topical preparations.

What does API stand for?

Active Pharmaceutical Ingredient.

What is a capsule?

A solid dosage form containing drug and excipients enclosed in an edible hard or soft shell.

What are the two main types of capsules?

Hard gelatin capsules and soft gelatin capsules.

What does DFC stand for?

Dry-Filled Capsule.

What type of capsule is a DFC?

Hard gelatin capsule.

What are hard gelatin capsules made of?

Gelatin, colorants, and opacifying agents.

What is the function of gelatin in a capsule?

Forms the capsule shell.

What is the function of colorants in capsules?

Provide color for identification and appearance.

What is an opacifying agent?

An ingredient that makes the capsule shell opaque (not see-through).

What is the most common opacifying agent discussed in class?

Titanium dioxide.

What is gelatin derived from?

Partial hydrolysis of collagen.

Where is collagen commonly obtained?

Bone and skin of porcine sources.

Is gelatin soluble in cold water?

No.

Is gelatin soluble in hot water?

Yes.

Is gelatin soluble in warm gastric fluid?

Yes.

According to USP-NF, what additives may gelatin contain?

Certified colors, sodium lauryl sulfate (SLS), and antimicrobial agents.

How much water do hard gelatin capsules contain?

13–16%.

What relative humidity should capsules be stored at?

35–65% RH.

What temperature should capsules be stored at?

15–25°C.

How are empty hard gelatin capsules manufactured?

Stainless steel pins are dipped into gelatin solution.

What happens after the pins are dipped into gelatin?

They are withdrawn, rotated, dried, stripped, and trimmed.

Are capsules manufactured before or after drug filling?

Before drug filling.

How are capsule halves joined together?

Colored gelatin bands or locking grooves.

What is the largest capsule size?

000.

What is the smallest capsule size?

5.

Arrange capsule sizes from largest to smallest.

000, 00, 0, 1, 2, 3, 4, 5.

Which is larger, Size 000 or Size 5?

Size 000.

How is the proper capsule size selected?

By experimentation and volume requirements.

What formula is used to determine how much powder fits into a capsule?

Weight = Volume × Bulk Density.

What is bulk density?

The mass of powder per unit volume.

Why is bulk density important?

It determines whether a dose will fit into a capsule.

How much powder fits into a Size 5 capsule (0.13 mL) if bulk density is 1.5 g/mL?

0.195 g or 195 mg.

Show the calculation for a Size 5 capsule with density 1.5 g/mL.

0.13 mL × 1.5 g/mL = 0.195 g = 195 mg.

A Size 0 capsule has a volume of 0.68 mL. How much powder can it hold if bulk density is 1.0 g/mL?

0.68 g or 680 mg.

A Size 0 capsule has a volume of 0.68 mL. How much powder can it hold if bulk density is 0.8 g/mL?

544 mg.

Why might a 700 mg dose not fit into a Size 0 capsule?

The capsule volume may be insufficient.

How can a 700 mg dose be made to fit into a Size 0 capsule?

Increase powder density or use a larger capsule.

Ten capsules each contain 3 mg drug. How much total drug is needed?

30 mg.

If only 10 mg tablets are available, how many tablets provide 30 mg drug?

3 tablets.

Why is capsule compounding useful?

Allows individualized dosing.

What is the punch method?

A manual capsule-filling technique.

When is the punch method commonly used?

Small-scale compounding.

What equipment besides the punch method can fill capsules?

Hand-operated and large-scale capsule-filling machines.

What is a diluent?

An excipient that adds bulk to a formulation.

Give examples of diluents.

Lactose, microcrystalline cellulose, and pregelatinized starch.

What is the function of lactose?

Diluent.

What is a glidant?

An excipient that improves powder flow.

What glidant was discussed in class?

Colloidal silicon dioxide (fumed silicon dioxide).

What is the function of colloidal silicon dioxide?

Improves powder flow.

What is a lubricant?

An excipient that reduces friction.

What lubricant was discussed in class?

Magnesium stearate.

What is the function of magnesium stearate?

Lubricant.

What is a surfactant?

An excipient that reduces surface tension.

What surfactant was discussed in class?

Lecithin.

What is the function of lecithin?

Surfactant.

What is the function of FD&C Blue #2?

Colorant.

What is the function of FD&C Red?

Colorant.

What is the function of titanium dioxide?

Opacifying agent.

Why are opacifying agents used?

To make capsules opaque.

What is the purpose of mixing and blending?

To produce a homogeneous mixture.

What factors affect mixing?

Blender type, blender size, load capacity, RPM, drug percentage, and formulation characteristics.

What should be avoided during mixing?

Demixing or segregation.

Why are capsules commonly compounded extemporaneously?

They permit individualized dosing.

How much extra powder should be prepared?

5–10% extra.

What mixing technique should be used when compounding capsules?

Geometric dilution.

Can liquids be incorporated into capsules?

Yes, if handled properly.

What adsorbent can be used for liquids or eutectic mixtures?

Magnesium carbonate.

What type of liquids can be placed in gelatin capsules without dissolving them?

Fixed oils.

What PPE should be worn when compounding capsules?

Gloves.

What information should be recorded about compounded capsules?

Capsule size and color.

What is the function of gelatin?

Capsule shell.

What is the function of lactose?

Diluent.

What is the function of microcrystalline cellulose?

Diluent.

What is the function of pregelatinized starch?

Diluent.

What is the function of colloidal silicon dioxide?

Glidant.

What is the function of fumed silicon dioxide?

Glidant.

What is the function of magnesium stearate?

Lubricant.

What is the function of lecithin?

Surfactant.

What is the function of FD&C Blue #2 and FD&C Red?

Colorants.

What is the function of titanium dioxide?

Opacifying agent.